BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF RESTOR

    MDR report key: 1200369 · Received October 10, 2008

    Report

    Report Number
    1119421-2008-00794
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    July 25, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ALCON RESEARCH, LTD. / HUNTINGTON
    Product Code
    MFK
    PMA / PMN Number
    P040020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE ASSOCIATED WITH THIS REPORT HAS NOT BEEN RECEIVED FOR EVALUATION; THE DEVICE REMAINS IMPLANTED. PRODUCT HISTORY RECORDS WERE REVIEWED AND ALL DOCUMENTS INDICATE THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED BY FAX AND MAIL ON 09/12/2008 AND BY PHONE ON 09/24/2008. A COMPLETED QUESTIONNAIRE WAS RECEIVED ON 09/26/2008.

    Description of Event or Problem · 1

    A TECHNICIAN REPORTS A PATIENT WITH MONOCULAR DIPLOPIA FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT SURGERY. IN A FOLLOW UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT AS "UNKNOWN", AND THE PROGNOSIS AS "POOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF RESTOR INTRAOCULAR LENS MFK ALCON RESEARCH, LTD. / HUNTINGTON SN6AD3 10732372

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other